Ursodeoxycholic acid Mylan Generics

Patient Information Leaflet

Acido Ursodesossicolico Mylan Generics 150 mg tablets, 300 mg tablets

ursodeoxycholic acid
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Acido Ursodesossicolico Mylan Generics is and what it is used for
2. What you need to know before taking Acido Ursodesossicolico Mylan Generics
3. How to take Acido Ursodesossicolico Mylan Generics
4. Possible side effects
5. How to store Acido Ursodesossicolico Mylan Generics
6. Contents of the pack and other information

1. What Acido Ursodesossicolico Mylan Generics is and what it is used for

Acido Ursodesossicolico Mylan Generics is a preparation based on naturally occurring bile acids present in the body, which are capable of solubilizing cholesterol in bile.
This medicinal product is used in adults to treat disorders of bile production by the liver and to improve the solubility of cholesterol-rich bile, both to prevent the formation of cholesterol stones and to facilitate the dissolution of existing ones. This medicine is not effective against all types of gallstones, but only against those not visible on X-rays (radiolucent stones); in particular, cholesterol gallstones in a functioning gallbladder (gallbladder with preserved function) and stones in the bile duct.
It is also used to treat digestive problems caused by gallbladder malfunction (biliary dyspepsia).
In children over 6 years of age, it is used for liver and gallbladder disorders associated with cystic fibrosis (a serious genetic disease).

2. What you should know before taking Acido Ursodesossicolico Mylan Generics

Do not take Acido Ursodesossicolico Mylan Generics

• if you are allergic (hypersensitive) to ursodeoxycholic acid, bile acids, or to any of the ingredients of this medicine (listed in section 6);
• if you have acute inflammation of the gallbladder (cholecystitis) or of the bile ducts;
• if you have a blockage of the bile ducts (obstruction of the common bile or cystic duct);
• if you frequently suffer from upper abdominal pain (biliary colic);
• if you have calcified gallstones visible on X-ray;
• if you have reduced gallbladder motility;
• if you are pregnant or breastfeeding;
• if you have active gastric or intestinal ulcers (gastric or duodenal ulcer);
• if you have yellowing of the skin (obstructive jaundice);
• if you have severe liver (severe hepatopathies) or kidney problems;
• if you have serious pancreatic or intestinal disorders that may affect the circulation of bile salts;
• if this medicine is intended for a child with congenital biliary malformations (biliary atresia) in whom portoenterostomy (surgical procedure to restore bile flow) has failed or bile flow has not been successfully restored.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Ursodesossicolico Mylan Generics.
Treatment with this medicine must be carried out under strict medical supervision.
Before starting long-term therapy, your doctor will monitor your liver function (assessment of transaminases and alkaline phosphatase).
During the first 3 months of treatment with this medicine, your doctor will check your liver function parameters every 4 weeks, and thereafter every 3 months. This allows evaluation of your response to therapy (in primary biliary cirrhosis) and detection of any potential liver damage.
When treating gallstone dissolution, an ultrasound imaging of the gallbladder (oral cholecystography) should be performed 6–10 months after starting treatment to assess clinical improvement.
Contact your doctor if, after starting treatment for advanced primary biliary cirrhosis, you experience worsening symptoms such as pruritus. In this case, the dose of ursodeoxycholic acid should be reduced to 250 mg once daily and then gradually increased (see section 3). Other formulations available on the market are suitable for this dosing regimen.
If you experience diarrhoea, consult your doctor, who may decide to reduce the dose or discontinue treatment.
This medicine is not suitable for the treatment of all types of gallstones; those most likely to dissolve are radiolucent (not visible on X-ray), small stones in a functioning gallbladder.

Other medicines and Acido Ursodesossicolico Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Acido Ursodesossicolico Mylan Generics together with the following medicines:

• bile acid sequestrants used to lower cholesterol levels, such as cholestyramine and colestipol, or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), as they reduce the effectiveness of this medicine. If these medicines are needed, they should be taken at least 2 hours before or after Acido Ursodesossicolico Mylan Generics;
• cyclosporine, a medicine that suppresses the immune system. In this case, your doctor must monitor blood levels of cyclosporine and adjust the dose accordingly;
• ciprofloxacin and dapsone, antibiotics used to treat infections;
• nitrendipine, a medicine used to lower blood pressure; in this case, an increase in the dose of nitrendipine may be required;
• estrogens and cholesterol-lowering agents such as clofibrate, which may promote gallstone formation;
• drugs that increase biliary cholesterol excretion (oral hormonal contraceptives, some lipid-lowering agents);
• medicines that are harmful to the liver (hepatotoxic).

Use this medicine with caution if you are taking rosuvastatin, a medicine used to lower blood cholesterol, as it may increase rosuvastatin blood levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine during pregnancy unless absolutely necessary. Before starting treatment, ensure that you are not pregnant.
If you are of childbearing age, you may start treatment with this medicine only if you are using a reliable contraceptive method (non-hormonal oral contraceptives or low-estrogen hormonal contraceptives).
If you are being treated for gallstone dissolution, use an effective non-hormonal contraceptive, since hormonal oral contraceptives may increase the risk of gallstone formation.

Driving and using machines
This medicine does not affect, or affects negligibly, the ability to drive or operate machinery.

Acido Ursodesossicolico Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Ursodeoxycholic Acid Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to your clinical condition and your tolerance
to the medicine.
Treatment of gallstones: to prevent the formation of stones, the recommended daily
dose is 5–10 mg/kg (i.e. 300–600 mg) per day, for long-term treatment.
Take the medicine during or after meals and in the evening.
To maintain suitable conditions for dissolving existing stones, treatment should last at least 4–6 months, which may be extended up to 12 months or longer, continuously. Treatment should be continued for 3–4 months after radiological or ultrasonographic disappearance of the stones. However, treatment should not exceed 2 years.
Treatment of dyspepsia (digestive problems) and maintenance therapy: the recommended dose is 300 mg per day, divided into two doses.
Use in children
In children with cystic fibrosis aged over 6 years, the recommended dose is 20 mg/kg/day, divided into 2–3 doses, with a possible increase to 30 mg/kg/day if necessary.
If you take more Ursodeoxycholic Acid Mylan Generics than you should
In case of overdose, you may experience diarrhoea. Generally, other symptoms of overdose are unlikely, as absorption of ursodeoxycholic acid decreases with increasing dose, resulting in greater excretion in faeces.
If you accidentally ingest an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Ursodeoxycholic Acid Mylan Generics
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• soft stools or diarrhoea.

Very rare (may affect up to 1 in 10,000 people)

• severe pain in the upper right abdomen;
• calcification of gallstones;
• serious liver problems (hepatic cirrhosis), which partially improve upon discontinuation of therapy;
• urticaria.

Occasionally, intestinal disturbances have been reported, which generally resolve while continuing treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ursodeoxycholic Acid Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month and to the product in its original packaging,
stored unopened and correctly preserved.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Ursodesossicolico Mylan Generics contains

• The active substance is ursodeoxycholic acid. Each tablet contains 150 mg or 300 mg of ursodeoxycholic acid.
• The other components are: lactose, microcrystalline cellulose, starch, magnesium stearate.

Description of the appearance of Acido Ursodesossicolico Mylan Generics and contents of the pack
Pack of 20 tablets of 150 mg.
Pack of 20 tablets of 300 mg.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, 10015 Ivrea (TO)